OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Nafamostat hydrochloride (CAS RN 80251-32-7) and nafamostat mesylate (CAS RN 82956-11-4). Nafamostat mesylate, also known as nafamostat mesilate, (6-amidino-2-naphthyl-pguanidinobenzoate dimethanesulfonate) is the mesylate salt form of nafamostat, a broadspectrum, synthetic serine protease inhibitor, with anticoagulant, anti-inflammatory, mucus clearing, potential antitumor, and potential antiviral activities (2, 3, 4). Nafamostat is used in Asian countries to improve acute symptoms of pancreatitis (acute pancreatitis, acute exacerbation phase of chronic pancreatitis, postoperative acute pancreatitis, acute pancreatitis after pancreatography, traumatic pancreatitis), treat disseminated intravascular coagulation (DIC), and prevent clotting of perfusing blood in extracorporeal blood circuit. Recently, in vitro studies revealed that nafamostat mesylate has antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and an antiinflammatory and anticoagulation effect. Clinical studies are currently ongoing to evaluate the clinical efficacy of nafamostat mesylate in adult patients hospitalized with COVID-19 pneumonia.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Nafamostat, just click the ADD TO CART button.

HBEL

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